Document is current

Article History

Received: 22 July 2025

Accepted: 10 October 2025

First Online: 24 November 2025

Declarations

:

: Andrea Antinori reports consulting fees from AstraZeneca, Bavarian Nordic, Gilead Sciences, Inc., GSK, Merck, Moderna, Pfizer, and ViiV Healthcare; and travel grants from Gilead Sciences, Inc. Yoshiyuki Yokomaku reports honoraria from Chugai Pharmaceutical, Denka, Gilead Sciences, Inc., Janssen Pharmaceuticals, MSD, Roche Diagnostics, and ViiV Healthcare; membership of Second Committee on Drugs, Pharmaceutical Affairs and Food Sanitation Council (PAFSC) and membership of Review Committee on Adverse Drug Reactions, Pharmaceuticals and Medical Devices Agency (PMDA). Hila Elinav reports research grants and honoraria from Gilead Sciences, Inc. and GSK/ViiV Healthcare; and participation in advisory boards for Gilead Sciences, Inc. and GSK/ViiV Healthcare. Hüsnü Pullukçu reports honoraria, travel grants, and other interests from Gilead Sciences, Inc., GSK, Ilko, and Pharmactive. Joss de Wet reports consulting fees and travel grants from Gilead Sciences, Inc. and ViiV Healthcare; and honoraria from and participation in advisory boards for Gilead Sciences, Inc., Merck, and ViiV Healthcare. Antonio Antela reports honoraria from and participation in advisory boards for Gilead Sciences, Inc., Janssen Cilag, and ViiV Healthcare; and travel grants from Gilead Sciences, Inc. Po-Liang Lu reports honoraria and travel grants from Gilead Sciences, Inc. Michael Sabranski reports travel grant from Gilead Sciences, Inc. Fabrice Bonnet reports research grants, honoraria, and travel grants from Gilead Sciences, Inc., MSD, and ViiV Healthcare; and consulting fees from Gilead Sciences, Inc. and ViiV Healthcare. Jan den Hollander reports consulting fees from Gilead Sciences, Inc., MSD, and ViiV Healthcare. Arthur Jackson reports participation in an advisory board for Mundipharma; and serving as chair of the Cork Fast Track City HIV Committee. Chiaw Yee Choy reports research grant from the National Centre for Infectious Diseases, honoraria for speaking at the Multi-Specialty Medical Mega Conference 2024 from the conference organisers, and unpaid board membership for Action for AIDS. David Thorpe, Andrea Marongiu, and James Jarrett are employees of, and hold stock in, Gilead Sciences, Inc. Rebecca Harrison is an employee of IQVIA, contracted to work with Gilead Sciences, Inc. Marta Boffito reports research grants from Gilead Sciences, Inc., Moderna, MRC, MSD, Sanofi, Valneva, and ViiV Healthcare; consulting fees from Gilead Sciences, Inc., GSK, MSD, Roche, and ViiV Healthcare; and honoraria from AstraZeneca, Gilead Sciences, Inc., MSD, Pfizer, and ViiV Healthcare. Yeon-Sook Kim, Weiping Cai, and Fujie Zhang have no conflicts of interest to report.

: Each study in this analysis was conducted in accordance with the protocol and ethical principles derived from international guidelines, including the Declaration of Helsinki of 1964 and its later amendments, Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation guidelines for Good Clinical Practice, and all applicable laws, rules, and regulations. The protocols for each study were approved by an institutional review board or ethics committee. The master ethics committees/central IRBs for the studies are as follows: BICSTaR Asia: National Health Group Domain, Specific Review Board Domain E; BICSTaR Canada: Veritas IRB Inc.; BICSTaR Europe: CPP – Ile-de-France – VII; Ethikkommission Der Läk Badenwürttemberg; Mater Misericordiae University Hospital Research Ethics Committee; Ethics Medical Research Committee Beaumont Hospital; Galway University Hospitals Clinical Research Ethics Committee; Clinical Research Ethics Committee Cork Teaching Hospitals; Comitato Etico Territoriale Lombardia 1; Metc Cmo Nijmegen; Metc Medisch Ethische Toetsingscommissie Utrechtmetc; Toetsingscommissie Wetenschappelijk Onderzoek Rotterdam; Ceic H. Bellvitge, Marmara University Pendik; Cec – Hrar; Ec-West Midlands – The Black Country; BICSTaR Israel: IL-LEC-Hadassah Medical Center Helsinki Committee; IL-LEC-Tel Aviv Sourasky Medical Center Helsinki Committee; IL-LEC-Kaplan Medical Center Helsinki Committee; IL-LEC-Rambam Health Care Center Helsinki Committee; IL-LEC-Sheba Medical Center Helsinki Committee; BICSTaR Japan: Institutional Review Board for Clinical Research of National Hospital, Organization Osaka National Hospital; Institutional Review Board for Clinical Research of National Hospital, Organization Nagoya Medical Center; Institutional Review Board for Clinical Research of National Hospital, Organization Kyushu Medical Center; Institutional Review Board for the Independent Clinical Research of Hokkaido University Hospital; Institutional Review Board for Clinical Research of National Center for Global Health and Medicine; China study: Ethics Committee of Beijing Ditan Hospital Capital Medical University; Medical Ethics Committee of Guangzhou Eighth People's Hospital. Written informed consent was obtained from all participants.